The Biologics eFOI Reading Room provides access to documents posted throughout the "Vaccines, Blood & Biologics" and other sections related to the Center for Biologics Evaluation and Research on the FDA.gov Web site. These documents are frequently requested by the public through the Freedom of Information Act.

Product Approval Information

• Biologics Products & Establishments
• Licensed Biological Products with Supporting Documents
• Substantially Equivalent 510(k) Device Information
• Premarket Approvals (PMAs) and Humanitarian Device Exemptions (HDEs)
• New Drug Applications (NDAs)
• Postmarketing Requirements and Commitments: Introduction
• Transfer of Therapeutic Products to the Center for Drug Evaluation and Research

Compliance, Surveillance & Enforcement

• Compliance Actions (Biologics)
• Compliance Programs (CBER)
• Recalls (Biologics)
• Warning Letters
• Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics
• BIMO/Team Biologics/Internet Surveillance/Other

Product Safety & Availability

• Blood Information & Recommendations
• Safety & Availability (Biologics)
• Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
• Vaccine Adverse Events
• CBER-Regulated Products: Shortages and Discontinuations

Meetings

• Allergenic Products Advisory Committee
• Blood Products Advisory Committee
• Cellular, Tissue, and Gene Therapies Advisory Committee
• Transmissible Spongiform Encephalopathies Advisory Committee
• Vaccines and Related Biological Products Advisory Committee
• Workshops, Meetings & Conferences (Biologics)

Talk Papers & Press Releases

• Press Announcements
• Newsroom

Additional Documents Available from FDA

• Electronic Reading Room
• Handbook for Requesting Information and Records from FDA
• Manual of Compliance Policy Guides
• FDA Forms
• Dockets Management
• Inspection Guides